Latest Update on the CLS(MD) Sandbox
Applications Open and Positive Response
Launched in October 2023, the CLS(MD) Sandbox program has garnered significant interest from medical device manufacturers. As of April 2024, the program has received over 20 applications, with the majority focusing on Levels 1 and 2 of the assessment process. The encouraging response reflects the industry's growing awareness of cybersecurity risks and the value proposition of the CLS(MD) label.
The program has completed preliminary reviews for Level 1 applications, and feedback has been sent to the respective companies for further action. This demonstrates the program's commitment to providing timely guidance and facilitating a smooth application process.
Approaching Deadline: Encourage Early Applications
The CLS(MD) Sandbox is scheduled to conclude on July 20, 2024. With the assessment process taking time, particularly for Levels 3 and 4, manufacturers interested in participating are urged to submit their applications as soon as possible. Early application allows for a more thorough review process and increases the chances of securing a CLS(MD) label at the scheme's launch.
Background: Cybersecurity Labelling Scheme for Medical Devices (CLS(MD))
A Collaborative Effort for Improved Medical Device Cybersecurity
The CLS(MD) scheme is a testament to Singapore's commitment to raising cybersecurity standards in the medical device industry. This collaborative initiative brings together the expertise of the MOH, CSA, HSA, and Synapxe to address the growing threat of cyberattacks on medical devices.
About Health Sciences Authority (HSA)
The HSA is Singapore's regulatory body for health products, including medical devices. They oversee the evaluation, registration, and market authorization of medical devices in the country. Their involvement in the CLS(MD) program ensures that cybersecurity considerations are integrated into the overall regulatory framework for medical devices.
About Cyber Security Agency of Singapore (CSA)
The CSA is Singapore's national agency for cybersecurity. They lead the nation's efforts to defend against cyber threats and promote a secure digital environment. Their expertise in cybersecurity is vital to the development and implementation of the CLS(MD) scheme.
About Synapse
Synapxe is a Singapore-based company with expertise in cybersecurity solutions. Their collaboration with the government agencies brings valuable industry knowledge and technical know-how to the CLS(MD) scheme.
Voluntary Scheme with Level-Based Assessments
The CLS(MD) scheme operates on a voluntary basis, allowing manufacturers to demonstrate their commitment to cybersecurity best practices. The program features four levels of assessments, each with varying degrees of rigor. These levels cater to the diverse cybersecurity needs of different medical devices, ensuring a comprehensive yet adaptable approach.
The CLS(MD) Label: Empowering Informed Decisions
The successful completion of a CLS(MD) assessment leads to the issuance of a label that signifies the level of cybersecurity provisions integrated into the medical device. This label empowers healthcare organizations and users to make informed purchasing decisions. By clearly indicating the device's cybersecurity posture, the CLS(MD) label fosters trust and transparency within the healthcare ecosystem.
Details of the Scheme
The CLS(MD) scheme applies to medical devices handling patient data or connecting to other systems. It offers four assessment levels (Levels 1-4) with increasing cybersecurity requirements, ensuring a comprehensive yet adaptable approach for various device complexities. Please refer to Qualtechs’ previous articles to know more about the details of the program:
- SINGAPORE: CYBERSECURITY LABELLING SCHEME FOR MEDICAL DEVICES SANDBOX
- SINGAPORE: ANNOUNCEMENT ON PUBLIC CONSULTATION FOR THE PROPOSED FRAMEWORK AND IMPLEMENTATION OF THE CYBERSECURITY LABELLING SCHEME FOR MEDICAL DEVICES [CLS(MD)]
Call to Action
The CLS(MD) Sandbox program offers a valuable opportunity for medical device manufacturers to gain a competitive advantage and demonstrate their commitment to cybersecurity. With the application deadline approaching on July 20, 2024, manufacturers are urged to act swiftly.
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References:
Cyber Security Agency of Singapore - CLS(MD) Sandbox
Synapxe | Cybersecurity Labelling Scheme for Medical Devices